Tagged as: FDA Approval

Mylan and Biocon Announce U.S. Launch of Insulin Glargine Biosimilar

We previously reported FDA approval of Mylan and Biocon’s NDA for SEMGLEE (insulin glargine injection).  Today, Mylan and Biocon announced the launch of SEMGLEE for the U.S. market.  SEMGLEE is a biosimilar of LANTUS, Sanofi’s long-acting insulin glargine product.  SEMGLEE will be available in vials and pre-filled pens.  The lead…

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FDA Approves Sandoz's Biosimilar Pegfilgrastim

As we have previously reported on Sandoz’s Biologics License Application (“BLA”) for its proposed biosimilar to Neulasta® (pegfilgrastim), Sandoz received a complete response letter from FDA, and had resubmitted its application after reportedly addressing the issues identified by FDA.  Yesterday, the FDA approved Sandoz’s application.  The biosimilar, named ZIEXTENZO, is an injectable formulation of pegfilgrastim-bmez, with…

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FDA Approves RUXIENCE, Pfizer’s Rituximab Biosimilar Product

On July 23, 2019, the FDA approved Pfizer’s aBLA for RUXIENCE (rituximab-pvvr), a biosimilar of Genentech’s RITUXAN.  According to its approved package insert, RUXIENCE is indicated for the treatment of certain types of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s Granulomatosis), and microscopic polyangiitis. RUXIENCE is the twenty-second…

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